ZETIA

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Zetia Adverse Events Reported to the FDA Over Time

How are Zetia adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Zetia, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Zetia is flagged as the suspect drug causing the adverse event.

Most Common Zetia Adverse Events Reported to the FDA

What are the most common Zetia adverse events reported to the FDA?

Myalgia	907 (4.44%)
Blood Creatine Phosphokinase Increa...	428 (2.1%)
Rhabdomyolysis	362 (1.77%)
Pain In Extremity	347 (1.7%)
Fatigue	332 (1.63%)
Asthenia	279 (1.37%)
Arthralgia	270 (1.32%)
Dizziness	263 (1.29%)
Muscular Weakness	259 (1.27%)
Diarrhoea	254 (1.24%)
Nausea	252 (1.23%)
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Muscle Spasms	220 (1.08%)
Dyspnoea	218 (1.07%)
Drug Ineffective	207 (1.01%)
Alanine Aminotransferase Increased	201 (.98%)
Hepatic Enzyme Increased	200 (.98%)
Back Pain	199 (.97%)
Pain	197 (.96%)
Abdominal Pain	195 (.95%)
Aspartate Aminotransferase Increase...	193 (.95%)
Headache	193 (.95%)
Liver Function Test Abnormal	162 (.79%)
Rash	157 (.77%)
Drug Interaction	155 (.76%)
Pancreatitis	153 (.75%)
Malaise	152 (.74%)
Blood Cholesterol Increased	142 (.7%)
Abdominal Pain Upper	135 (.66%)
Vomiting	130 (.64%)
Oedema Peripheral	127 (.62%)
Renal Failure Acute	126 (.62%)
Pruritus	122 (.6%)
Constipation	118 (.58%)
Chest Pain	115 (.56%)
Fall	114 (.56%)
Gait Disturbance	112 (.55%)
Myocardial Infarction	103 (.5%)
Renal Failure	103 (.5%)
Liver Disorder	93 (.46%)
Weight Decreased	93 (.46%)
Pyrexia	91 (.45%)
Adverse Event	90 (.44%)
Paraesthesia	90 (.44%)
Insomnia	88 (.43%)
Depression	83 (.41%)
Blood Creatinine Increased	82 (.4%)
Alopecia	79 (.39%)
Feeling Abnormal	79 (.39%)
Abdominal Distension	78 (.38%)
Abdominal Discomfort	77 (.38%)
Myopathy	75 (.37%)
Blood Triglycerides Increased	74 (.36%)
Flatulence	74 (.36%)
Hepatic Function Abnormal	73 (.36%)
Pancreatitis Acute	72 (.35%)
Pneumonia	71 (.35%)
Urticaria	71 (.35%)
Cholelithiasis	68 (.33%)
Hypoaesthesia	67 (.33%)
Medication Error	67 (.33%)
Blood Alkaline Phosphatase Increase...	66 (.32%)
Death	66 (.32%)
Hepatitis	66 (.32%)
Low Density Lipoprotein Increased	66 (.32%)
International Normalised Ratio Incr...	63 (.31%)
Anaemia	59 (.29%)
Gamma-glutamyltransferase Increased	57 (.28%)
Hypersensitivity	57 (.28%)
Muscle Disorder	55 (.27%)
Tremor	55 (.27%)
Overdose	54 (.26%)
Dyspepsia	53 (.26%)
Blood Glucose Increased	52 (.25%)
Myositis	52 (.25%)
Atrial Fibrillation	51 (.25%)
Hepatic Failure	51 (.25%)
High Density Lipoprotein Decreased	51 (.25%)
Swollen Tongue	51 (.25%)
Jaundice	50 (.24%)
Rash Pruritic	50 (.24%)
Abasia	49 (.24%)
Joint Swelling	49 (.24%)
Palpitations	49 (.24%)
Amnesia	46 (.23%)
Burning Sensation	46 (.23%)
Muscle Atrophy	46 (.23%)
Dehydration	45 (.22%)
Dysphagia	45 (.22%)
Weight Increased	45 (.22%)
Blood Bilirubin Increased	44 (.22%)
Musculoskeletal Stiffness	44 (.22%)
Musculoskeletal Pain	43 (.21%)
Oedema	43 (.21%)
Urinary Tract Infection	43 (.21%)
Diabetes Mellitus	42 (.21%)
Swelling Face	42 (.21%)
Chills	40 (.2%)
Chromaturia	40 (.2%)
Neck Pain	40 (.2%)
Confusional State	39 (.19%)
Coronary Artery Disease	39 (.19%)

Share/Embed Graph Export Data

This graph shows the top adverse events submitted to the FDA for Zetia, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Zetia is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Zetia

What are the most common Zetia adverse events reported to the FDA?

Muscle	2061 (10.09%)
Gastrointestinal Signs	1142 (5.59%)
Hepatobiliary	890 (4.36%)
Neurological	839 (4.11%)
Musculoskeletal And Connective Tiss...	805 (3.94%)
Epidermal And Dermal Conditions	702 (3.44%)
Hepatic And Hepatobiliary	653 (3.2%)
Enzyme	557 (2.73%)
Therapeutic And Nontherapeutic Effe...	520 (2.55%)
Gastrointestinal Motility And Defec...	449 (2.2%)
Joint	441 (2.16%)
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Respiratory	413 (2.02%)
Lipid Analyses	376 (1.84%)
Renal Disorders	325 (1.59%)
Infections - Pathogen Unspecified	299 (1.46%)
Injuries	274 (1.34%)
Exocrine Pancreas Conditions	271 (1.33%)
Medication Errors	233 (1.14%)
Headaches	222 (1.09%)
Coronary Artery	219 (1.07%)
Hematology Investigations	210 (1.03%)
Cardiac Arrhythmias	186 (.91%)
Renal And Urinary Tract Investigati...	171 (.84%)
Cardiac And Vascular Investigations	167 (.82%)
Physical Examination Topics	166 (.81%)
Skin Appendage Conditions	161 (.79%)
Sleep Disorders	142 (.7%)
Urinary Tract Signs	142 (.7%)
Gallbladder	132 (.65%)
Allergic Conditions	129 (.63%)
Movement Disorders	115 (.56%)
Mental Impairment	106 (.52%)
Electrolyte And Fluid Balance Condi...	105 (.51%)
Vision	104 (.51%)
Depressed Mood Disorders	97 (.48%)
Metabolic, Nutritional And Blood Ga...	97 (.48%)
Anxiety Disorders	96 (.47%)
Central Nervous System Vascular	96 (.47%)
Cardiac Disorder Signs	95 (.47%)
Angiedema And Urticaria	93 (.46%)
Body Temperature Conditions	93 (.46%)
Glucose Metabolism Disorders	90 (.44%)
Anemias Nonhemolytic And Marrow Dep...	88 (.43%)
Ocular Infections, Irritations And ...	88 (.43%)
Oral Soft Tissue Conditions	88 (.43%)
Tongue Conditions	88 (.43%)
Appetite And General Nutritional	82 (.4%)
Bone And Joint Injuries	81 (.4%)
Fatal Outcomes	81 (.4%)
Gastrointestinal Hemorrhages	81 (.4%)
Decreased And Nonspecific Blood Pre...	79 (.39%)
Ocular Structural Change, Deposit A...	76 (.37%)
Upper Respiratory Tract Disorders	68 (.33%)
Eye	65 (.32%)
Gastrointestinal Conditions	65 (.32%)
Arteriosclerosis, Stenosis, Vascula...	64 (.31%)
Deliria	62 (.3%)
Lifestyle Issues	62 (.3%)
Viral Infectious	62 (.3%)
Heart Failures	60 (.29%)
Bone Disorders	58 (.28%)
Inner Ear And Viiith Cranial Nerve	58 (.28%)
Water, Electrolyte And Mineral	58 (.28%)
Dental And Gingival Conditions	56 (.27%)
Vascular	56 (.27%)
Platelet	54 (.26%)
Seizures	54 (.26%)
Peripheral Neuropathies	52 (.25%)
Lower Respiratory Tract Disorders	50 (.24%)
Neuromuscular	50 (.24%)
Suicidal And Self-injurious Behavio...	49 (.24%)
Psychiatric	48 (.24%)
Bacterial Infectious	47 (.23%)
Gastrointestinal Inflammatory Condi...	47 (.23%)
Skin Vascular Abnormalities	47 (.23%)
Embolism And Thrombosis	43 (.21%)
Bile Duct	42 (.21%)
Gastrointestinal Neoplasms Malignan...	41 (.2%)
Immunology And Allergy	41 (.2%)
White Blood Cell	39 (.19%)
Gastrointestinal Stenosis And Obstr...	38 (.19%)
Investigations, Imaging And Histopa...	38 (.19%)
Myocardial	37 (.18%)
Fungal Infectious	34 (.17%)
Salivary Gland Conditions	34 (.17%)
Mood Disorders	32 (.16%)
Musculoskeletal And Connective Tiss...	32 (.16%)
Vascular Hemorrhagic	32 (.16%)
Miscellaneous And Site Unspecified ...	31 (.15%)
Musculoskeletal And Soft Tissue Inv...	31 (.15%)
Vascular Hypertensive	31 (.15%)
Bronchial Disorders	29 (.14%)
Protein And Chemistry Analyses	29 (.14%)
Therapeutic Procedures And Supporti...	29 (.14%)
Disturbances In Thinking	28 (.14%)
Gastrointestinal	27 (.13%)
Tendon, Ligament And Cartilage	26 (.13%)
Gastrointestinal Ulceration And Per...	25 (.12%)
Hearing	25 (.12%)
Procedural And Device Related Injur...	25 (.12%)
Nephropathies	24 (.12%)

Share/Embed Graph Export Data

This graph shows the top categories of adverse events submitted to the FDA for Zetia, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Zetia is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Zetia According to Those Reporting Adverse Events

Why are people taking Zetia, according to those reporting adverse events to the FDA?

Blood Cholesterol Increased	3036
Hypercholesterolaemia	1791
Hyperlipidaemia	944
Product Used For Unknown Indication	866
Blood Cholesterol	570
Drug Use For Unknown Indication	510
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Dyslipidaemia	263
Blood Cholesterol Abnormal	116
Type Iia Hyperlipidaemia	102
Low Density Lipoprotein Increased	98
Blood Triglycerides Increased	75
Cardiac Disorder	69
Coronary Artery Disease	67
Lipids Increased	57
Hypertension	39
Hypertriglyceridaemia	30
Metabolic Disorder	21
Lipids Abnormal	21
Ill-defined Disorder	19
Diabetes Mellitus	14
Prophylaxis	13
Blood Cholesterol Decreased	13
High Density Lipoprotein Decreased	11
Lipid Metabolism Disorder	11
Lipids	10
Myocardial Ischaemia	9
Low Density Lipoprotein	9
Arteriosclerosis	9
Mixed Hyperlipidaemia	9
Type Ii Hyperlipidaemia	8
Tachycardia	8
Blood Pressure	8
Cardiovascular Event Prophylaxis	5
Myocardial Infarction	5
High Density Lipoprotein Increased	5
Blood Triglycerides Abnormal	5
Type 2 Diabetes Mellitus	5
Blood Triglycerides	5
Low Density Lipoprotein Decreased	4
Hepatic Steatosis	4
Dyspepsia	4
Hypocholesterolaemia	3
Liver Function Test Abnormal	3
Cerebrovascular Accident	3
Diabetes Mellitus Non-insulin-depen...	3
Hyperchloraemia	3
Drug Intolerance	3
Acute Myocardial Infarction	3
Ldl/hdl Ratio	3
Gastric Disorder	2
Peripheral Vascular Disorder	2

Drug Labels

Label	Labeler	Effective
Zetia	A-S Medication Solutions LLC	08-SEP-09
Zetia	Physicians Total Care, Inc.	29-DEC-09
Zetia	Rebel Distributors Corp	26-JAN-11
Zetia	Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC	19-MAR-12
Zetia	Cardinal Health	10-APR-12
Zetia	Merck Sharp & Dohme Corp.	13-FEB-13
Zetia	Cardinal Health	29-APR-13
Zetia	Cardinal Health	29-APR-13

Zetia Case Reports

What Zetia safety concerns are being reported by doctors and researchers in the medical literature?

About Results

This report contains aggregated drug side effects and adverse events for Zetia. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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